Unilateral thalamotomy for Parkinson's (NCT04991831)
Reduce unilateral tremor with Exablate
- Trial ID
- NCT04991831
- Official Title
- A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
- Goal
- Reduce unilateral tremor with Exablate
- Status
- RECRUITING
- Sponsor
- InSightec
- Study Type
- OBSERVATIONAL
- Enrollment
- 50 participants
- Conditions
- Tremor Associated With Tremor Dominant Parkinson's Disease
- Interventions
- Unilateral thalamotomy
Summary For Families
The goal is to follow people with tremor-dominant Parkinson's whose tremor does not respond to medications, to see how well a one-sided procedure controls that disabling tremor over time. It uses the Exablate MR-guided focused ultrasound system to heat and destroy a very small area in the motor thalamus on one side of the brain, reducing tremor on the opposite hand without opening the skull. Because the procedure targets the brain circuit that produces tremor, it does not change how levodopa works for other Parkinson's symptoms, though better tremor control may reduce the need for extra tremor medicines. Adults aged 30 to 99 who are already scheduled to receive a unilateral Exablate thalamotomy as part of their usual care and who can sign consent and attend follow-up visits are eligible to join this registry.
Locations
- Miami Neuroscience Institute Baptist Health, Miami, Florida, United States
- Rush University, Chicago, Illinois, United States
- Brigham and Women's Hospital, Boston, Massachusetts, United States
- Weill Cornell Medicine, New York, New York, United States
- Novant Health Brain & Spine Surgery, Huntsville, North Carolina, United States
- Cleveland Clinic Foundation, Cleveland, Ohio, United States
- Miami Valley Hospital, Fairborn, Ohio, United States
- University of Dundee, Dundee, Scotland, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Unilateral thalamotomy. The goal is to follow people with tremor-dominant Parkinson's whose tremor does not respond to medications, to see how well a one-sided procedure controls that disabling tremor over time. It uses the Exablate MR-guided focused ultrasound system to heat and destroy a very small area in the motor thalamus on one side of the brain, reducing tremor on the opposite hand without opening the skull. Because the procedure targets the brain circuit that produces tremor, it does not change how levodopa works for other Parkinson's symptoms, though better tremor control may reduce the need for extra tremor medicines. Adults aged 30 to 99 who are already scheduled to receive a unilateral Exablate thalamotomy as part of their usual care and who can sign consent and attend follow-up visits are eligible to join this registry.
- Who can participate?
- Participants must be between 30 Years and 99 Years.
- Where is this trial located?
- This trial is recruiting at 8 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 7 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Assessments are collected at Baseline, 1, 3, 6, and 12 months after the Exablate procedure and then annually for 5 years.